Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Drug: Rapid withdrawal of antiepileptic; Drug: Slow withdrawal of antiepileptic

• Registration Number: NCT05236166
• Lead Sponsor: University Magna Graecia

Brief Summary

The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-26
• Primary Completion: 2021-05-01
• Study Completion: 2021-11-01
• Study First Submitted: 2022-01-18
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria)
• age at epilepsy onset of 16 years or older
• seizure freedom for at least 2 years
• treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide)
• adherence to the protocol and visit schedules.

Exclusion Criteria

• inability to understand the aims or modalities of the study;
• current pregnancy or plans to become pregnant during withdrawal period;
• history of seizure relapse after discontinuation of treatment;
• history of psychogenic non-epileptic seizures (PNES);
• history of status epilepticus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid withdrawal	Rapid withdrawal of antiepileptic	Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).
Slow withdrawal	Slow withdrawal of antiepileptic	Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).

Primary Outcome Measures

Name	Time	Method
Time to seizure relapse	365 days	Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

Secondary Outcome Measures

Name	Time	Method
Patients' compliance with the assigned withdrawal schedule	365 days	Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
Severity of relapses and mortality	365 days	Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality

Trial Locations

Locations (1)

Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro; 🇮🇹 Reggio Calabria, Italy